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PharmaCompass offers a list of Docusate Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Docusate Sodium manufacturer or Docusate Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Docusate Sodium manufacturer or Docusate Sodium supplier.
PharmaCompass also assists you with knowing the Docusate Sodium API Price utilized in the formulation of products. Docusate Sodium API Price is not always fixed or binding as the Docusate Sodium Price is obtained through a variety of data sources. The Docusate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Docusate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Docusate Sodium, including repackagers and relabelers. The FDA regulates Docusate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Docusate Sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Docusate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Docusate Sodium supplier is an individual or a company that provides Docusate Sodium active pharmaceutical ingredient (API) or Docusate Sodium finished formulations upon request. The Docusate Sodium suppliers may include Docusate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Docusate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Docusate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Docusate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Docusate Sodium DMFs exist exist since differing nations have different regulations, such as Docusate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Docusate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Docusate Sodium USDMF includes data on Docusate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Docusate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Docusate Sodium suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Docusate Sodium Drug Master File in Japan (Docusate Sodium JDMF) empowers Docusate Sodium API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Docusate Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Docusate Sodium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Docusate Sodium suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Docusate Sodium Drug Master File in Korea (Docusate Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Docusate Sodium. The MFDS reviews the Docusate Sodium KDMF as part of the drug registration process and uses the information provided in the Docusate Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Docusate Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Docusate Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Docusate Sodium suppliers with KDMF on PharmaCompass.
A Docusate Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Docusate Sodium Certificate of Suitability (COS). The purpose of a Docusate Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Docusate Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Docusate Sodium to their clients by showing that a Docusate Sodium CEP has been issued for it. The manufacturer submits a Docusate Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Docusate Sodium CEP holder for the record. Additionally, the data presented in the Docusate Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Docusate Sodium DMF.
A Docusate Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Docusate Sodium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Docusate Sodium suppliers with CEP (COS) on PharmaCompass.
A Docusate Sodium written confirmation (Docusate Sodium WC) is an official document issued by a regulatory agency to a Docusate Sodium manufacturer, verifying that the manufacturing facility of a Docusate Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Docusate Sodium APIs or Docusate Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Docusate Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Docusate Sodium suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Docusate Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Docusate Sodium API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Docusate Sodium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Docusate Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Docusate Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Docusate Sodium suppliers with NDC on PharmaCompass.
Docusate Sodium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Docusate Sodium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Docusate Sodium GMP manufacturer or Docusate Sodium GMP API supplier for your needs.
A Docusate Sodium CoA (Certificate of Analysis) is a formal document that attests to Docusate Sodium's compliance with Docusate Sodium specifications and serves as a tool for batch-level quality control.
Docusate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Docusate Sodium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Docusate Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Docusate Sodium EP), Docusate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Docusate Sodium USP).
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